Laboratory Supplement for the Final Study Report on the Developmental Toxicity Evaluation for Berberine Chloride Dihydrate (CAS No. 5956-60-5) Administered in the Feed to Sprague-Dawley (CD (Trade Name)) Rats on Gestational Days 6 through 20

摘要

The purpose of this task was to perform a limited characterization for two batches of berberine chloride dihydrate. The results for all analysis were consistent between the two batches. The test article was identified as berberine chloride dihydrate by infrared and nuclear magnetic resonance spectroscopies. Purity profile analysis by high performance liquid chromatographt dtected five impurities with a combined area of approximately 1.7% relative to the total peak area. The area percent for the major component was approximately 98.3%. Drying under vacuum at ambient temperatures resulted in a weight loss of approximately 10.6%, reported as water content. Based on the combined data for both batches, the purity of the test articles was determined to be approximately 87.7%, expressed as berberine chloride.